Validation of a New Rapid Detection Test for Detection of Neisseria meningitidis A/C/W/X/Y Antigens in Cerebrospinal Fluid

Abstract

Meningococcal meningitis remains a life-threatening disease worldwide, with high prevalence in the sub-Saharan meningitis belt. A rapid diagnosis is crucial for implementing adapted antimicrobial treatment. We describe the performances of a new immunochromatographic test (MeningoSpeed, BioSpeedia, France) for detecting and grouping Neisseria meningitidis. Cerebrospinal fluids (CSFs) were collected from 5 African countries and France. For the rapid diagnostic test (RDT), the CSF sample was deposited on each of the 3 cassettes for a total volume of 90 μl. The results of the RDT were compared to those of a reference multiplex PCR assay detecting the major serogroups of N. meningitidis on 560 CSF specimens. Five specimens were found uninterpretable by RDT (0.9%). The results of interpretable specimens were as follows: 305 positive and 212 negative samples by both techniques, 14 positive by PCR only, and 24 positive by RDT only (sensitivity, specificity, and positive and negative predictive values of 92.7%, 93.8%, 95.6%, and 89.8%, respectively, with an accuracy of 93.2% and a kappa test of 0.89; P < 0.05). From 319 samples positive by PCR for serogroups A, C, W, X, or Y, the grouping results were concordant for 299 specimens (sensitivity of 93.0%, 74.4%, 98.1%, 100%, and 83.3% for serogroups A, C, W, X, and Y, respectively). The MeningoSpeed RDT exhibited excellent performances for the rapid detection of N. meningitidis antigens. It can be stored at room temperature, requires a minimal amount of CSF, is performed in 15 minutes or less, and is easy to use at bedside.

Field Evaluation of the Performance of Two Rapid Diagnostic Tests for Meningitis in Niger and Burkina Faso

“…Our results suggest a higher sensitivity of the RDT in detecting NmC in this field context than previously reported in laboratory conditions (95% versus 65%) [15]. This could be due to the fact that the circulating clone in Niger and Burkina Faso (NmC, clonal complex ST-10217) [19,22] is particularly well detected by the antibodies used in the MeningoSpeed test.…”

“…The rapid diagnostic tests (RDT) were first developed at the Institut Pasteur, Paris, as immunochromatographic tests [ 13 , 14 ]. They were thereafter transferred the BioSpeedia company who then developed MeningoSpeed and PneumoSpeed that can be used between 2 and 30 °C to diagnose, respectively, the five main meningococcal serogroups (A, C, W, X and Y) [ 15 ] found in the African meningitis belt and Sp meningitis. The tests are based on the use of antibodies directed against capsular polysaccharide of Nm (serogroups A, C, W, Y, and X) and against pneumococcal cell wall polysaccharide C that is common to all Sp isolates.…”

Molecular diagnostic assays for the detection of common bacterial meningitis pathogens: A narrative review

“…The different types of LFAs include those in which antibodies are used as recognition elements (‘lateral flow immunoassays’). An example of this is the MeningoSpeed rapid diagnostic test, an immunochromatographic test that can detect meningococcal serogroups from CSF samples [21] . Other LFAs consist of antigen-antibody interactions with specific tagged doubled-stranded amplicon detection after PCR (‘nucleic acid lateral flow immunoassay’) or assays where specific nucleic acid amplicons are hybridised with immobilised complementary probes (‘nucleic acid lateral flow assay’) [20] .…”

Next generation rapid diagnostic tests for meningitis diagnosis

“…The BioSpeedia MeningoSpeed test, capable of detecting Nm serogroups A, C, W, Y, and X has laboratory verification values ranging from 95.6-100% for sensitivity and 93.9-100% for specificity, when compared to either culture or PCR (BioSpeedia, 2020). Field sensitivity and specificity, when compared to PCR, were 92.7% and 93.8%, respectively at the species level; and 74.4-100% and 98.0%-100%, respectively at the serogroup level (Haddar et al, 2020). Collard et al, 2014).…”

“…There are plans to incorporate the detection of NmB into future versions of the product. The antibodies will also be further developed to improve test performance (Haddar et al, 2020). Overall, meningitis lateral flow test performance generally meets the WHO's acceptable criteria for meningitis RDTs.…”